Active Ingredient: Deutetrabenazine
Deutetrabenazine is indicated for the treatment of moderate to severe tardive dyskinesia in adults.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 12 milligrams deutetrabenazine, once daily, over the duration of 1 week. Afterwards, oral, 24 milligrams deutetrabenazine, once daily, over the duration of 1 week. Afterwards, oral, between 24 milligrams deutetrabenazine and 48 milligrams deutetrabenazine, once daily. The maximum allowed total dose is 48 milligrams deutetrabenazine daily.
Deutetrabenazine dosing should be determined individually for each patient, based on adequate reduction of tardive dyskinesia symptoms and tolerability.
Therapy should be initiated at 12 mg once daily for one week. The dose should then be increased to 24 mg once daily for another week. After the second week, it is recommended that the dose be titrated at weekly intervals in increments of 6 mg once daily, based on reduction of tardive dyskinesia symptoms and tolerability. The efficacious dose range is considered to be 24 mg to 48 mg. The maximum recommended daily dose is 48 mg.
In patients receiving strong CYP2D6 inhibitors or who are poor CYP2D6 metabolisers, the daily dose of deutetrabenazine should not exceed 36 mg.
A decision to continue treatment with deutetrabenazine should be taken on an individual patient basis.
Treatment can be continued for as long as a therapeutic benefit is observed, and the patient tolerates treatment.
Treatment with deutetrabenazine can be discontinued without the need for tapering off.
If a patient misses doses for less than one week, treatment can be resumed at the current dose. If the patient misses doses for more than one week, deutetrabenazine therapy should be restarted at 12 mg once daily.
There is limited data available on the use of deutetrabenazine in patients ≥65 years of age. Based on the results of population pharmacokinetic analysis, no dose adjustment is required.
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